Term
| What are the JCM (Joint Commission Medication) Management Standards |
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Definition
Should:
1. Provide framework for an effective and safe medication management system
2. Measure, asses, and improve performance
3. Reasonable,achievable,surveyable |
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Term
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Definition
| drugs benefit can be safely achieved and outweigh the risk of harm |
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Term
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Definition
| Risk Evaluation and Mitigation Strategies |
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Term
| Under what circumstance does the FDA require REMS |
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Definition
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Term
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Definition
1. Medication guides
2. Communication plan
3. Elements to Assure Safe Use (ETASU)
4. Implementation System |
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Term
| Do all REMS require a medication guide |
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Definition
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Term
| When are medication guides required by REMS |
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Definition
1. When a drug is dispensed in an outpatient setting
2. When requested by patient
3. The first time a drug is dispensed |
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Term
| How is the communication plan element of REMS used? |
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Definition
Provider letters
Disseminated through professional societies |
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Term
| Describe the Elements to Assure Safe Use element of REMS |
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Definition
1. Provider training
2. Certifications for pharmacies, providers...
3. Registry enrollments for patients, providers...
4. Restricted dispensing
5. Labs before dispensing
6. Patient monitoring |
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Term
| The iPledge program which was established for isotretinoin is an example of what REM element? |
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Definition
| ETASU (elements to assure safe use) |
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Term
| How often must drug sponsor's evaluate REMS? |
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Definition
| 18mo, 3yrs, and 7yrs after the REM was approved |
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Term
| Can REMS be modified or eliminated |
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Definition
Yes
Example: Rosaglitazone - CVD events --> Restricted use (REMs) ---> further study determined not an issue --> REM modified |
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Term
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Definition
| NON-STERILE compounding standards |
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Term
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Definition
| STERILE compounding standards |
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Term
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Definition
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Term
| If a FDA Form 483 is issued the facility is |
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Definition
| Out of compliance with FDA standards |
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Term
| In addition to including many of the requirements of USP 795, Chapter 797 also includes |
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Definition
PPE
Personnel Qualifications
Facilities ISO class reqs |
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Term
| T/F An Iso class 3 is a more stringent on particle counts than an ISO class 8 |
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Definition
| True. An ISO class 3 facility can only have 35.2 particle count/m^3 |
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Term
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Definition
Federal response to NECC
Title 1: Drug compounding
Title 2: Drug Supply Chain |
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Term
| Describe Maryland's response to NECC |
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Definition
HB 986
1. Any facility that performs STERILE compounding for MD patients must have a MD compounding permit
2. Entities that STERILE compound for office use or distribution must have MD Wholesalers Permit and FDA 503B registration |
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Term
| 797-Can compounding facilities compound without a prescription |
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Definition
| Yes in limited quantities |
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Term
| 797-How much extra drugs can compounding facilities distribute out of state? |
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Definition
| No more than 5% of total prescriptions dispensed |
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Term
| 797-Are outsourcing facilities required to be a licensed pharmacy? |
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Definition
| No - but licensed pharmacist must supervise |
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Term
| 797-T/F Outsourcing facilities must comply with cGMP? |
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Definition
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Term
| Can products from outsourcing facilities be resold? |
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Definition
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Term
| Is USP 800 more concerned with patients or healthcare workers |
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Definition
| healthcare workers exposure to hazardous drugs |
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